Merck downplayed severe psychological side-effects of its blockbuster children’s asthma drug

A slew of lawsuits against Merck allege the company has covered up links between its asthma drug and serious effects on patients’ mental health.

Since the German pharmaceutical giant launched its Singulair pills in 1998, the drug has been linked to dozens of suicides, cases of depression and anxiety.

Merck, who did not disclose the impact Singulair may have on psychological health, cited the medication early on as a safe way to help asthmatic children breathe easier with minimal to no effects on their developing brains, adding that the side effects were ‘usually mild’. and ‘comparable to a placebo’.

But an investigation by the Food and Drug Administration (FDA) into reports of serious side effects found that between 1998 and 2019, there were 82 suicides associated with the active ingredient in Singulair, 19 of which were confirmed in children under 17.

Singulair is extremely common in the US, with about nine million prescriptions filled for it each year.

Virginia native Nicholas England fatally shot himself in the head at age 22, just weeks after taking the generic version of Singulair

Australian-born Harrison Sellick attempted suicide when he was just five years old, a few years after going on Singulair. His mother Vanessa said he started having “really long meltdowns” from the age of two, as well as “general comments about death and self-loathing.”

No class action lawsuit is pending against Merck yet, but the past three years have seen a barrage of lawsuits across the U.S. in hopes of holding the company accountable for what many grieving parents believe is negligence and failure to warn for serious health risks.

Singulair has been a huge cash cow for Merck, generating about $50 billion in revenue.

It is an incredibly common medicine for asthma. In 2020, the total number of prescriptions for Singulair and its generic version called montelukast exceeded 31 million.

It is usually used alongside a corticosteroid inhaler, which can intercept an asthma attack when it comes on.

The FDA received thousands of reports of adverse mental health reactions to montelukast in the decade following its approval.

The reports earned another warning to be placed on the drug’s label in 2008, pointing to its possible psychiatric risks.

Litigants in the growing number of lawsuits against Merck have argued not only that the company designed and marketed a defective drug, but also that it concealed from the public the very real effects it could have on neurological health.

Plaintiffs suing Merck for negligence have focused on a specific patent from 2004 which many believe proves that the company knew the medication, commonly known as montelukast, could affect the brain. The patent states that montelukast may be able to treat a condition called cerebral spasms.

Following the FDA’s initial 2008 warning, spurred by reports of severe depression and agitation in patients, Austrian cell biologist Julia Marschallinger began investigating whether the drug could have applications for treating dementia in the elderly.

Later research by Dr. Marschallinger and her colleagues at the Institute of Molecular Regenerative Medicine in Salzburg found promising results pointing to its ability to reduce inflammation in the brain and improve memory in aging animals.

The Austrian researchers said in 2015 that “a significant amount of” montelukast “had reached the brain” by crossing the blood-brain barrier, a network of blood vessels and tissue that serves as a protective layer that lines the inside of the brain and keeps toxins out.

As good as this news was for dementia research, it could potentially be taxing for Merck, who urged the FDA in 1998: ‘Studies in rats with radiolabeled montelukast indicate minimal distribution across the blood-brain barrier.’

The FDA drew on Dr. Marschallinger’s research in 2020 when it rationalized to issue a new black box warning, the most serious kind the agency can implement, to post on Singulair.

The warning certain that “because of the risk of mental health side effects, the benefits of montelukast may not outweigh the risks in some patients, especially when disease symptoms are mild and adequately treated with other drugs.”

Dr. Marschallinger’s findings have also been cited in numerous lawsuits against Merck in cases of alleged negligence.

In one case it was ultimately decided in favor of Merck in 2021, the parents of an alleged victim named RSB said their child suffered “neuropsychiatric injuries” and was institutionalized.

RSB’s parents argued that because montelukast can cross the blood-brain barrier, “it exerts a systemic effect on the central nervous system that results in adverse neuropsychiatric events.”

“Plaintiffs further argue that the risk of new neuropsychiatric events is greater in pediatric patients.”

One such adversely affected pediatric patient was Melbourne, Australian-born Harrison Sellick.

According to his mother Vanessa, Harrison was prescribed montelukast when he was two years old, but developed behavioral problems and suicidal thoughts over the next three years.

Ms Sellick told Daily Mail Australia that her son, now 17 and off medication, attempted suicide at the age of five: ‘He had really long breakdowns that could last an hour and a half. There were general remarks about death and self-loathing.’

Meanwhile, in Virginia, 22-year-old Nicholas England fatally shot himself in the head in 2017, just two weeks after starting the generic version of Singulair.

His parents, who have attempted legal action against the drug companies, said their son had no prior mental health issues prior to the suicide.

But the Englands had no legal remedies against Merck or the generic manufacturer Teva Pharmaceuticals.

Most lawsuits against Merck are in the early stages, but the company has already had some legal success by using an argument known as preemption, which argues that federally regulated products or services, such as an FDA-approved drug, are immune should be for lawsuits alleging violations of state law.

In the 2021 RSB case, decided in favor of Merck, drugmakers relied on the preemption argument.

DailyMail.com has reached out to Merck for comment, but has not yet heard back.